Exit Interview: US FDA’s Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible’

The departing director of the US Food and Drug Administration’s Center for Drug Evaluation and Research believes her staff is in “the best place possible” as it enters the new year and a new administration under President-elect Donald Trump.

However, Patrizia Cavazzoni also wishes FDA review memos that result in complete response letters could be publicly released to better inform the drug development process and patients.

Cavazzoni, who has led the drugs center since 2020, will retire from the agency on 18 January.

Her departure plans took many in the agency by surprise, including Commissioner Robert Califf, who reportedly found out the night before the 10 January announcement. Califf named Principal Deputy Center Director Jacqueline Corrigan-Curay acting CDER director after Cavazzoni leaves.

The FDA declined to make Cavazzoni available for a press interview upon her retirement announcement.

Her virtual appearance on a panel of FDA product center directors at the 12 January CERSI Innovations in Regulatory Science Summit in San Francisco may be viewed as a public exit interview, even though her impending retirement was not mentioned during the session.

She shared thoughts on the staff she’s leaving behind at CDER, the heroic work undertaken to get a Baxter injectables facility devastated by Hurricane Helene back online, and transparency of agency/sponsor communications.

Strong Culture, Talented People

Cavazzoni highlighted CDER staff hiring and retention as among her center’s key successes in 2024.

“As we enter this year, we are in the best place possible when it comes to our staff,” she said. “In fact, this year, we had to dial back hiring a little bit because obviously we have finite budgets and we were so successful in hiring and hiring very talented staff across the programs.”

FDA user fee program data show that CDER hired 27 full-time equivalents, or 87% of its PDUFA VII hiring goal of 31 positions, for fiscal year 2024 as of 31 December. For FY 2025, CDER had filled seven of 15 positions by the end of December.

“We can’t get anything done and we cannot talk about successes unless we have a strong culture and talented people.”

FDA’s Patrizia Cavazzoni

“We’ve done a lot of work when it comes to … culture that has led us to have very low attrition,” Cavazzoni said. “We have actually the lowest attrition at FDA.”

“And so this is obviously the foundation, because we can’t get anything done and we cannot talk about successes unless we have a strong culture and talented people,” she added.

Agency officials and outside observers worry that FDA staff morale and retention will decline once the Trump administration enters, particularly if it eliminates telework flexibilities that agency employees have enjoyed since long before the COVID-19 pandemic.

Cavazzoni also flagged CDER’s ongoing work to modernize the advisory committee system as a key success. The work included perfecting CDER’s process for preparing and presenting at meetings, as well as refining the committees and expanding the pool of special government employee experts.

“We use more and more temporary members in advisory committees to make sure that we have the fit-for-purpose expertise for the questions that are being discussed in that particular advisory committee,” she said.

‘Massive Effort’ At Baxter Plant

Along with the center’s 50th biosimilar approval and ongoing work to decrease opioid overdose deaths, Cavazzoni highlighted the “massive effort” to bring Baxter’s North Cove facility in Marion, NC, back online after it was damaged by heavy rain and extensive flooding from Hurricane Helene in September. The site is the largest manufacturer of intravenous and peritoneal dialysis products in the US.

The FDA allowed temporary importation of some products, released an immediately-in-effect guidance on temporary compounding policies for certain parenteral products and extended the shelf life dates for some previously released product lots to address the threat of shortages presented by the facility’s closure and remediation.

The company restarted manufacturing at the site in November. As of 19 December, Baxter had restarted eight of 10 manufacturing lines, which represent about 85% of total pre-hurricane capacity.

“This is a sterile fluid facility. There was mud up the walls, two or three feet up the walls going into the production lines,” Cavazzoni said. “This was a massive effort.”

The FDA had a large team working with Baxter, including staff at the site. Thanks to federal officials and “a tremendous effort by the manufacturer … we were able to bring that facility back online in 60 days, [which] really is remarkable,” she said.

Publish Reviews Of Unapproved Drugs

Before the FDA center directors’ forum, the CERSI meeting featured a debate between Mathai Mammen, CEO and chairman of Parabilis Medicines, and Donna Boyce, senior VP and head-global regulatory sciences at Pfizer, on whether the FDA should be more transparent in reporting sponsor-level decisions.

“I would love to be able to publish our reviews for products that we do not approve that receive complete responses.”

Patrizia Cavazzoni

Mammen and Boyce, who took respective pro and con positions, discussed the potential benefits and detriments of disclosing preapproval data and FDA complete response letters, along with many other FDA/sponsor transparency-related issues that have been raised over the years.

During the FDA center directors’ forum, moderator Kuldev Singh, professor of ophthalmology at Stanford University, asked if the FDA should be more transparent in publicly reporting sponsor-level decisions.

“Do you ever lie awake at night thinking, ‘Gosh, if I could get this information out there, it would be better for the public if I could share this information more broadly?’” Singh asked.

Cavazzoni was the first to respond.

“I would love to be able to publish our reviews for products that we do not approve that receive complete responses,” she said. “There is a lot to be learned from failure, and I think that it would be the right thing to do for the patients, for the public, but also for shared learning across development programs. And unfortunately, we cannot do that because of confidentiality constraints.”